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Completed

NCT Number: NCT00366951

A Randomized Study on Comparing the Efficacy of Foley Catheter and Extraamniotic Saline Infusion for Labor Induction

Our purpose was to compare the efficacy and safety of Foley catheter with oxytocin and extraamniotic saline infusion with oxytocin for induction of labor requiring cervical ripening.

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Key information

Conditions

Cervical Ripening Labor, Induced

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

Induction of labor is indicated when the benefit to either the mother or fetus outweighs that of continuing the pregnancy. Labor induction in the presence of an unripened cervix is associated with prolonged labor, chorioamnionitis, and cesarean delivery. Numerous mechanical and pharmacological methods have been used for cervical ripening. There are limited numbers of rigorous studies comparing the efficacy of the various methods. One of the most common mechanical methods for cervical ripening is placement of a Foley catheter with a 30 cc balloon inside the cervix, with or without the use of oxytocin. The Foley balloon will disrupt the amniotic membrane surface and cause the release of prostaglandin, a natural chemical from the cervix, to facilitate the ripening process. Oxytocin will be used concurrently as the induction agent. Recently, a modification of this method, extraamniotic saline infusion (EASI) has become more popular. The EASI method involves similar procedure including the placement of Foley catheter inside the cervix; in addition, saline solution will be infused through the catheter. This additional step is thought to further facilitate the disruption of amniotic membrane surface. Both methods are safe and become the standard treatment for cervical ripening. However, there are no published trials so far comparing the two methods. The objective of this study is to compare the efficacy and safety of Foley catheter with oxytocin and EASI with oxytocin for induction of labor requiring cervical ripening. The study is designed to be a single masked randomized trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • singleton gestation
  • cephalic vertex presentation
  • intact membrane
  • gestational age between 30 and 42 weeks
  • Bishop score less than or equal to 5

Exclusion criteria

  • suspected chorioamnionitis
  • placenta previa
  • low lying placenta
  • unexplained vaginal bleeding
  • intrauterine fetal demise
  • HIV
  • any contraindication to vaginal delivery

Treatment and study plan

Foley catheter only

Procedure

Extraamniotic saline infusion

Procedure

Primary outcomes

  1. The time interval from placement of Foley catheter to vaginal delivery

Secondary outcomes

  1. Cesarean delivery rate

  2. Incidence of maternal complications

  3. Incidence of neonatal complications

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

A Randomized Clinical Trial Comparing the Efficacy and Safety of Foley Catheter Balloon With Oxytocin and Extraamniotic Saline Infusion (EASI) With Oxytocin for Induction of Labor Requiring Cervical Ripening

Important dates

Study start
2004
Study completion
2005
First posted
Aug 22, 2006
Registry last updated
Jan 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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